Thalomid Approved For Newly Diagnosed Multiple Myeloma

SUMMIT, N.J., May 25, 2006 -- Celgene Corporation announced that
the U.S. Food and Drug Administration (FDA) has granted accelerated
approval to its Supplemental New Drug Application (sNDA) for
Thalomid (thalidomide) in combination
with dexamethasone for the
treatment of newly diagnosed multiple myeloma. The
effectiveness of Thalomid is based upon response rates. There are
no controlled trials demonstrating a clinical benefit, such as an
improvement in survival. Multiple myeloma is the second most common
blood cancer in the United States affecting approximately 50,000
people. About 14,600 new cases of multiple myeloma are diagnosed
each year and about 12,000 Americans are expected to die of
multiple myeloma in 2006.

Thalomid is available through a Thalomid Education and
Prescribing Safety System, called S.T.E.P.S.(R). Through the use of
our S.T.E.P.S. program, more than 130,000 U.S. patients have had
safe access to Thalomid since its market introduction in July 1998.
This FDA approval for the indication of Thalomid in the treatment
of newly diagnosed multiple myeloma allows physicians and their
patients to be treated with another therapy option for this
incurable blood cancer.

The safety profile for Thalomid in multiple myeloma has shown an
increase in side effects with Thalomid and dexamethasone as
compared to dexamethasone alone. The most common adverse events
were constipation, sensory neuropathy, confusion, hypocalcemia,
edema, dyspnea, thrombosis/embolism, and rash/desquamation,
occurring in 20% of patients with a frequency less than or equal to
10% in patients treated with Thalomid/dexamethasone compared with
dexamethasone alone.

Safety Notice

Thalomid (thalidomide) Capsules 50 mg, 100 mg, & 200
mg

WARNING: If thalidomide is taken during pregnancy, it can
cause severe birth defects or death to an unborn baby. Thalidomide
should never be used by women who are pregnant or who could become
pregnant while taking the drug. Even a single dose, one capsule (50
mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe
birth defects. Because thalidomide is present in the semen of male
patients, males receiving thalidomide must always use a latex
condom during sexual contact with women of childbearing potential
even if he has undergone a successful vasectomy. Thalidomide can
only be marketed under a special restricted distribution program.
This program is called the "System for Thalidomide Education and
Prescribing Safety (S.T.E.P.S.(R)). Under this program, only
registered prescribers and pharmacists may dispense the drug. In
addition, patients must be advised of, agree to and comply with the
requirements of S.T.E.P.S.

The use of Thalomid (thalidomide) in multiple myeloma results in
an increased risk of venous thromboembolic events, such as deep
venous thrombosis and pulmonary embolus. This risk increases
significantly when thalidomide is used in combination with standard
chemotherapeutic agents including dexamethasone. In one controlled
trial, the rate of venous thromboembolic events was 22.5% in
patients receiving thalidomide in combination with dexamethasone
compared to 4.9% in patients receiving dexamethasone alone (p =
0.002). Patients and physicians are advised to be observant for the
signs and symptoms of thromboembolism. Patients should be
instructed to seek medical care if they develop symptoms such as
shortness of breath, chest pain, or arm or leg swelling.
Preliminary data suggests that patients who are appropriate
candidates may benefit from concurrent prophylactic anticoagulation
or aspirin treatment.

Thalidomide is contraindicated in patients who have demonstrated
hypersensitivity to the drug and its components. It is not known
whether Thalomid is excreted in human milk. Because of the
potential for adverse reactions in nursing infants, a decision
should be made whether to discontinue nursing or the drug, taking
into account the importance of the drug to the mother. Thalidomide
is known to cause nerve damage that may be permanent. Peripheral
neuropathy is a common, potentially severe, side effect of
treatment with thalidomide that may be irreversible. Decreased
white blood cell counts, including neutropenia, have been reported
in the clinical use of thalidomide. In placebo controlled clinical
trials of HIV-seropositive patient populations, there have been
reports of increased plasma HIV RNA levels associated with
thalidomide therapy. The most frequently reported adverse events
were constipation (55%), sensory neuropathy (54%), confusion (28%),
hypocalcemia (72%), edema (57%), dyspnea (42%), thrombosis/embolism
(23%), and rash/desquamation (30%) (occurring in >20% of
patients and with a frequency >10% in patients treated with
Thalomid/dexamethasone compared with dexamethasone alone). Patients
should be advised about these associated adverse events and
routinely monitored by a physician during treatment with
thalidomide. Patients should be instructed to not extensively
handle or open thalidomide capsules and to maintain storage of
capsules in blister packs until ingestion.

About Thalomid

Thalomid (thalidomide), manufactured by Celgene Corporation,
received U.S. Food and Drug Administration (FDA) clearance on July
16, 1998 for the acute treatment of cutaneous manifestations of
moderate to severe erythema nodosum leprosum (ENL) and as
maintenance therapy for prevention and suppression of the cutaneous
manifestations of ENL recurrence. Thalidomide is not indicated as
monotherapy for ENL treatment in the presence of moderate to severe
neuritis. Thalidomide is indicated for use as a treatment in
combination with dexamethasone for newly diagnosed multiple
myeloma.

About Multiple Myeloma

Multiple myeloma (also known as myeloma or plasma cell myeloma)
is a cancer of the blood in which malignant plasma cells are
overproduced in the bone marrow. Plasma cells are white blood cells
that help produce antibodies called immunoglobulins that fight
infection and disease. However, most patients with multiple myeloma
have cells that produce a form of immunoglobulin called paraprotein
(or M protein) that does not benefit the body. In addition, the
malignant plasma cells replace normal plasma cells and other white
blood cells important to the immune system. Multiple myeloma cells
can also attach to other tissues of the body, such as bone, and
produce tumors. The cause of the disease remains unknown.

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